Clinical Data Reviewer
Here is an exciting pharmaceutical job one of the industry's most prestigious organisations. There is a vacancy for a Clinical Data Reviewer to join a global top 10 pharmaceutical company at their offices located in Surrey. The Clinical Data Reviewer (CDR) performs full-time clinical data review, most often in a submission timeline, and works in conjunction with study teams' data review. The studies supported by the CDR are often, but not exclusively, comparative safety and efficacy (phase 3) trials that are high-enrolling and require robust data capture. Review tasks include both point-to-point data checks and interpretive analysis that requires that the CDR be knowledgeable about the therapeutic area under investigation, expected effects of the investigational drug and supportive medications, and possess sufficient clinical knowledge to assess if patient data is logical. They can be flexibly deployed to support multiples assets in different therapeutic areas, as needed.
The CDR would be expected to cooperate closely with the US based group of contract CDRs being managed by the global Data Review Team Lead. Home based work is possible, however, regular presence at the company WO offices 1-2 days a week is expected to allow team interaction with clinicians and clinical scientists, and coaching.
Skills and Requirements:
- Bachelor's degree or equivalent in life sciences, and significant Clinical Research experience in industry/CRO, in the phase 3/pivotal space. Advanced degree (PhD, PharmD, MD) is an advantage.
- Expertise in conduct of clinical trials, particularly understanding of the processes associated with delivery of quality data, and experience in the review of clinical study data.
- Technical data review skills enabling the review of large sets of clinical data under often challenging timelines, eg. Oracle Clinical Remote Data Capture, Microsoft Excel.
- Understanding of the processes associated with delivery of quality data, including at least basic knowledge of data management (eg. case report forms, electronic edit checks, interpretation of data status reports). Field monitoring experience (CRA role) is an advantage.
- Excellent communication skills (written and spoken) in English.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
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A full job description is available on request.
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